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OpenTrials
Active, Not Recruiting

NCT Number: NCT04360538

Long Term Outcomes of Patients With COVID-19

The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Critical Illness COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

About this study

The aim of this proposal to is to understand the extent and degree of physical disability, psychological sequelae, and cognitive dysfunction survivors of COVID-19 related critical illness will have upon hospital discharge, 6 months, and up to one year post discharge. These outcomes of interest will be evaluated prospectively. The investigators will perform these measures in Covid-19 patients with respiratory failure and compare them to non-Covid-19 patients with respiratory failure. The investigators also seek to determine the risk factors of these long-term complications in order to guide providers as to which patients should be screened for these deficits. Finally, the investigators will examine the association of various critical care interventions such as invasive versus noninvasive mechanical ventilation or use of sedatives and their effects on disability and cognitive dysfunction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients admitted to the ICU

Exclusion criteria

  • none

Treatment and study plan

Quality of life

Other

Physical disability assessment tool

Other names: SF-36

Impact Event Score

Other

Psychological Sequelae assessment tool

Other names: IES-R

Hospital Anxiety and Depression Scale

Other

Psychological Sequelae assessment tool

Primary outcomes

  1. Quality of Life score

    Time frame: up to 12 months after discharge

    SF-36 score

Secondary outcomes

  1. cognitive dysfunction

    Time frame: up to 12 months after discharge

    Montreal Cognitive Assessment (MoCA) score

  2. Functional Status Score

    Time frame: up to 12 months after discharge

    (FSS-ICU)

  3. Physical Disability

    Time frame: up to 12 months after discharge

    MRC neuromuscular Assessment

  4. Psychological Sequelae

    Time frame: up to 12 months after discharge

    Impact Event Score

Other outcomes

  1. hospital anxiety and depression

    Time frame: up to 12 months after discharge

    hospital anxiety and depression scale

  2. ICU related complications

    Time frame: hospitalization up to 6 weeks

    including ventilator associated pneumonia, GI hemorrhage, Deep Vein Thrombosis (DVT) /Pulmonary Embolus (PE), sacral decubitus ulcer, delirium, ICU acquired weakness

  3. hospital discharge location

    Time frame: hospital discharge up to 6 weeks

    measure the location (home, rehabilitation center, nursing home

  4. lCU length of stay

    Time frame: hospitalization up to 6 weeks

    number of days admitted to the ICU

  5. hospital length of stay

    Time frame: hospitalization up to 6 weeks

    number of days admitted to the hospital

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Acronym: COVID19 LTFU

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2020
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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